Butuca Anca, Stoicescu Laurentiu, Popa Mirela Livia, Dobrea Carmen Maximiliana, Muntean Adriana, Morgovan Claudiu, Pienar Corina, Gligor Felicia Gabriela, Ghibu Steliana, Popa Ilie Ioana Rada, Frum Adina
Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Internal Medicine Department, Faculty of Medicine, "Iuliu Haţieganu" University of Medicine and Pharmacy, 400000 Cluj-Napoca, Romania.
J Clin Med. 2025 May 13;14(10):3409. doi: 10.3390/jcm14103409.
Effective immunosuppressant pharmacotherapy is essential for successful organ transplantation. : Generally, induction therapy includes basiliximab (BAS) or anti-thymocyte globulin (THY). However, other biological molecules have been used to accelerate firm immunosuppression. A reduced effectiveness of these induction agents increases the risk of graft rejection. This study aims to evaluate the ineffectiveness rate of biological molecules based on spontaneous reports uploaded to the EudraVigilance database. : Specific topics related to the safety profiles of alemtuzumab, BAS, belatacept, and THY were analyzed. A total of 23 preferred terms describing drug resistance, drug ineffectiveness, and transplant rejection were used as the inclusion criteria. Descriptive and disproportionality analyses were performed. : Regarding the four molecules, 18,564 safety reports were communicated, with = 5089 (27.4%) for THY and = 3469 (18.7%) for BAS. Most adverse drug reactions (ADRs) for THY, BAS, and belatacept affected the adult male population. As expected, the majority of the ADRs were linked to infections, followed by general disorders. BAS presented higher probabilities of drug resistance and transplant rejection being reported among the four molecules. A higher probability of reporting drug ineffectiveness was noted for THY than for the other molecules. : All the molecules showed small frequencies regarding resistance. As expected, transplant rejection was more frequently reported for all molecules (especially for BAS), accompanied by a notable variability in reporting frequencies. However, a causal relationship between the reported adverse reactions and drug efficacy cannot be established based on the present results. Further real-world evidence studies will enhance our understanding of the safety and efficacy of these drugs in transplant patients.
有效的免疫抑制药物治疗对于器官移植成功至关重要。一般来说，诱导治疗包括巴利昔单抗（BAS）或抗胸腺细胞球蛋白（THY）。然而，其他生物分子也已被用于加速强效免疫抑制。这些诱导剂有效性的降低会增加移植排斥的风险。本研究旨在基于上传至欧洲药物警戒数据库的自发报告评估生物分子的无效发生率。分析了与阿仑单抗、BAS、贝拉西普和THY安全性概况相关的特定主题。总共使用23个描述耐药性、药物无效和移植排斥的首选术语作为纳入标准。进行了描述性和不成比例性分析。关于这四种分子，共传达了18564份安全报告，其中THY为5089份（27.4%），BAS为3469份（18.7%）。THY、BAS和贝拉西普的大多数药物不良反应（ADR）影响成年男性人群。正如预期的那样，大多数ADR与感染有关，其次是全身疾病。在这四种分子中，BAS出现耐药性和移植排斥报告的概率更高。THY报告药物无效的概率高于其他分子。所有分子的耐药频率都较低。正如预期的那样，所有分子（尤其是BAS）移植排斥的报告更为频繁，报告频率存在显著差异。然而，根据目前的结果无法确定所报告的不良反应与药物疗效之间的因果关系。进一步的真实世界证据研究将增进我们对这些药物在移植患者中的安全性和有效性的理解。
